FDA Policy/General
Public health officials and former FDAers are expressing concern that by hastily allowing unproven coronavirus antibody tests on the market and by authorizing emergency use of hydroxychloroquine FDA is risking losing its hard-won credibility as the gold standard for world health agencies. An in-depth McClatchy News article says
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Bedfont Scientific, Kent, United Kingdom (2/12): FDA inspected the company 10/2019 and cited GMP issues with its carbon monoxide gas analyzers. For example, Bedfont failed to establish
Drugs
Some 56 pro-life and other advocacy groups are urging FDA to seize the Web site domains for AidAccess, Rablon, and any other entities illegally prescribing and/or selling mifepristone in the U.S. “We urge FDA to protect women from the distributors of abortion-inducing drugs who place lives
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide.” The document is intended to help small entities comply with the final rule on the classification of posterior cervical screw systems. It says that while posterior cervical screw systems
FDA Policy/General
[Review by Jim Dickinson] The global Covid-19 pandemic has brought accountability to the forefront for both the regulated industry and regulators, law book author Roseann B. Termini tells FDA Webview in a brief statement. “Compliance is critical and Congress has demanded that FDA step up enforcement of possible fraudulent
FDA Policy/General
DEVICES FDA has approved Roche’s cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. Previously, plasma viral load results required blood samples to be cooled during transport to the lab. The new device allows quantitative testing of patients with HIV living in remote areas
FDA Policy/General
Novo Nordisk says its diabetes drug Victoza (liraglutide) injection 1.2 mg or 1.8 mg reduced the risk of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo in a recent trial involving 9,340 adults. “Victoza is the only approved
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).” The revision describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0620). FDA regulations (21 CFR part 516) specify, among other things, the criteria and procedures for requesting eligibility
FDA Policy/General
After years of stagnation, the vaccines development industry is likely to see a renaissance under pressure from the Covid-19 pandemic, predicts Alliance for a Stronger FDA. In a 5/1 commentary, Alliance deputy executive director Steven Grossman writes that the pandemic will lead to a resurgence in the moribund
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Information Sharing Among Constituent Part Applicants — 21 CFR 4.103 (OMB Control Number 0910-0834).” The collection request applies to requirements under the Postmarketing Safety Reporting Rule for Combination Product for Constituent Part Applicants to share specified
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the Covid-19 Public Health Emergency.” The document communicates the agency’s intention not to enforce certain requirements for the onsite monitoring activities and
FDA Policy/General
Federal Register notice: FDA has postponed a 6/9-planned Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting. Panel members were set to review a Refocus Group PMA for the VisAbility Micro Insert, indicated for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between
FDA Policy/General
Federal Register notice: FDA has announced a new date, 6/30, for an earlier postponed public meeting entitled “Modernizing FDA’s Data Strategy.” The agency has also extended the comment period for a 1/8 Federal Register notice on approaches to data quality, data stewardship, data exchange, and data analytics.
FDA Policy/General
Federal Register notice: FDA has announced that a 5/4 public workshop entitled “FY2020 Generic Drug Regulatory Science Initiatives” is being modified to take place remotely. Participants are also asked to submit either electronic or written comments on the workshop by 6/4. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Health Solutions Pharmacy Center, Corvallis, OR (3/31): FDA inspected the firm in January and cited serious deficiencies in its practices for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.” FDA is required to establish a pilot program under which testing laboratories may be accredited to assess the conformance of a device within certain FDA-recognized standards. Determinations by
FDA Policy/General
Unilife Corp. and Amgen have entered into a strategic collaboration for injectable drug delivery systems. According to the companies, Unilife has granted Amgen exclusive rights to Unilife’s wearable injectors within select drug classes for use with certain Amgen assets, while preserving rights previously granted to other Unilife customers. Also,
FDA Policy/General
Federal Register notice: FDA announces it is contemplating a grant of an exclusive patent license to Sciogen (San Jose, CA) for two patents: 1. U.S. Patent No. 9,163,068 issued 10/20/2015 and entitled “Influenza Virus Recombinant Proteins” 2. U.S. Patent No. 9,896,484 issued
FDA Policy/General
Federal Register notice: FDA has reopened for 60 days the comment period for a 1/3 Federal Register notice seeking input from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations on the Office of Minority Health and Health Equity Strategic Priorities. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Imports and Electronic Import Entries”(OMB Control Number 0910-0046). The revision pertains to a weekly entry filing program that is available for some FDA-regulated products, and it allows entry filers to file a single entry
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Drug Supply Chain Security Act Implementation” (OMB Control Number 0910-0806). The revision is mandated under the Drug Supply Chain Security Act (DSCSA) and pertains to certain provisions of the DSCSA to also include information collection activity